MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? possible lot numbers are j2017450, j2003933 and j2022013.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.Was another drain needed to correct the situation? the surgery was completed using a new drain.If yes, was the new drain placed surgically during a second procedure? the new drain was placed during the first procedure.Device return status : we regularly contact with sales rep about the device returning.No further information will be provided.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: lot: j2017450, expiration date: 6/8/2025; lot: j2003933 , expiration date: 2/6/2025; lot: j2022013, expiration date: 8/5/2025.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a ventricular septal defect surgery on (b)(6) 2021 and a drain was used.During surgery, when placing the drain, the surgeon noticed that there was a pin hole on the drain, so use was stopped.The new drain was placed during the first procedure.Further details are not provided.There were no adverse consequences to the patient.

• Brand Name: BLAKE (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12094375
• MDR Text Key: 259217135
• Report Number: 2210968-2021-05952
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1